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Clinical Trial Summary

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.


Clinical Trial Description

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield. Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06004440
Study type Observational [Patient Registry]
Source Intuitive Surgical
Contact Heather Golden, MSc, CCRP
Phone 8105697006
Email heather.golden@intusurg.com
Status Recruiting
Phase
Start date September 21, 2023
Completion date August 2027

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